BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 15200932 · Received August 10, 2022

    Report

    Report Number
    2124215-2022-28190
    Event Type
    Injury
    Date Received
    August 10, 2022
    Date of Event
    July 1, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THROMBUS OCCURRED. ON (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PATIENT WAS DISCHARGED WITH PRESCRIPTIONS FOR AN ORAL ANTICOAGULANT (OAC) AND ASPIRIN. AFTER A ROUTINE FOLLOW UP EXAMINATION ON (B)(6) 2022, THE PATIENT WAS INSTRUCTED TO DISCONTINUE ASPIRIN. ON (B)(6) 2022, DURING A TRANSESOPHAGEAL ECHOCARDIOGRAM, A LAMINAR THROMBUS MEASURING 10MM BY 30MM WAS DISCOVERED ON THE FACE OF THE CLOSURE DEVICE. OAC DOSAGE WAS INCREASED FOLLOWING DISCOVERY OF THE THROMBUS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522531 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027534837

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other